AstraZeneca and Daiichi Sankyo said Enhertu (trastuzumab deruxtecan) has received a positive opinion in the European Union as a monotherapy for adults with unresectable or metastatic HER2‑positive (IHC 3+) solid tumors who have been previously treated and have no satisfactory treatment options. The recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is based on data from HER2‑positive subgroups across three Phase II trials – DESTINY‑PanTumor02, DESTINY‑Lung01 and DESTINY‑CRC02 – in which Enhertu showed responses across multiple tumor types.
In DESTINY‑PanTumor02, previously treated patients with centrally or locally assessed IHC 3+ solid tumours (n=111) – including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other tumours – achieved a confirmed objective response rate (ORR) of 51.4% and a median duration of response (DOR) of 14.2 months. In DESTINY‑Lung01, patients with centrally confirmed IHC 3+ non‑small cell lung cancer (NSCLC) (n=17) had a confirmed ORR of 52.9% and median DOR of 6.9 months. DESTINY‑CRC02 showed a confirmed ORR of 46.9% and median DOR of 5.5 months in patients with centrally confirmed IHC 3+ colorectal cancer (n=64). The safety profile in these studies was consistent with prior Enhertu trials, with no new safety concerns identified.
Susan Galbraith, executive vice president, Oncology Haematology R&D at AstraZeneca, said HER2‑directed therapies have already changed care in some HER2‑expressing cancers such as breast and gastric cancer, but many other HER2‑overexpressing tumours still lack targeted options. She said the positive CHMP opinion highlights the role of precision oncology and represents a step toward offering a new targeted treatment to more patients in the EU with HER2‑positive solid tumours.
John Tsai, global head of R&D at Daiichi Sankyo, said the opinion recognizes the clinical value of Enhertu as a potential first HER2‑directed medicine and antibody–drug conjugate for patients with HER2‑positive metastatic solid tumours in the EU. He noted that Enhertu provides responses for patients with advanced HER2‑overexpressing cancers who have limited options and said the companies will continue working with the EMA to bring the drug to this population.
Enhertu, a specifically engineered HER2‑directed DXd antibody–drug conjugate discovered by Daiichi Sankyo, is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. It already has a tumor‑agnostic indication in the US and other countries based on DESTINY‑PanTumor02. Additional EU regulatory submissions for Enhertu are under review, including its use with pertuzumab as first‑line therapy for unresectable or metastatic HER2‑positive (IHC 3+ and ISH+) breast cancer based on the DESTINY‑Breast09 Phase III trial, and for patients with HER2‑positive (IHC 3+ and ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2‑targeted treatment, supported by data from the DESTINY‑Breast05 Phase III trial.
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